A Study to Evaluate the Effect of the Treatment of Anemia on Myocardial Glucose Uptake (MGU) in Patients With Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change to Myocardial Glucose Uptake as Measured by Fluoro-deoxy-D-glucose (FDG) Positron Emission Tomography (PET) Scan From Pre-treatment Compared to 6 Months After Anemia Therapy Initiation.
研究概览
简要总结
This study examines patients with chronic kidney disease-related anemia and measures changes in the metabolism of the heart using FDG/PET scanning, before and 6 months after their health-care provider has initiated anemia management therapy with the FDA-approved drug darbepoetin alfa (Aranesp), which is approved for chronic kidney disease-related anemia. The investigators hypothesize that the heart has abnormal metabolism with the anemia of chronic kidney disease but this improves after correction of this anemia with darbepoetin alfa.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant must receive care at the VAMHCS (VA Hospital) in Baltimore
- •Diagnosed with CKD stage 3 to 5 (eGFR of 60 ml/min/1.73m2) and not expected to initiate renal replacement therapy within 6 months
- •Anemia related CKD.
- •The last 2 serum hemoglobin (Hb) values less than 11.0 gm/dl but greater than 8.0 gm/dl
- •Greater than 18 years of age
- •Assessed to be clinically stable by the clinician
排除标准
- •Need for hemodialysis, peritoneal dialysis, or transplantation at the time of enrollment or projected to start within 6 months after enrollment
- •Low functional capacity including inability to walk a flight of stairs with a bag of groceries (NYHA Class III/IV Heart Failure)
- •Prior erythropoietic agents within last 12 weeks
- •TSAT < 15% and not receiving the recommended dose for iron deficiency
- •Uncontrolled hypertension defined as greater than 180 mm Hg systolic or 110 mm Hg diastolic
- •Potentially "brittle" diabetes with the propensity for symptomatic hypoglycemia after a 6 hour fast
- •New diagnosis or ongoing therapy for Cancer
- •Pregnancy
结局指标
主要结局
Change to Myocardial Glucose Uptake as Measured by Fluoro-deoxy-D-glucose (FDG) Positron Emission Tomography (PET) Scan From Pre-treatment Compared to 6 Months After Anemia Therapy Initiation.
时间窗: 6 months
Change in myocardial glucose uptake from baseline to 6 months expressed as change in micromol/min/100 g
次要结局
未报告次要终点
研究者
Jeffrey Fink
Professor, Nephrology (primary); Epidemiology (secondary)
University of Maryland, Baltimore